Phase IIIb VISIBLE Trial Shows Efficacy of Tremfya Treating Scalp Psoriasis in People of Color
Tremfya achieved the co-primary endpoints of Scalp-Specific Investigator Global Assessment score of 0/1 and Psoriasis Scalp Severity Index 90 response at week 16 in the trial.
Image credit: pongmoji | stock.adobe.com
Johnson & Johnson has announced positive results from the Phase IIIb VISIBLE clinical trial for Tremfya (guselkumab) in the treatment of scalp psoriasis. According to the results, the treatment produced major improvements not only in scalp psoriasis clearance, but also to scalp itch reduction and patient-reported health-related quality of life outcomes at 16 weeks in people of color.1
Key findings from Cohort B of the study show that approximately 7 in 10 patients administered Tremfya achieved the co-primary endpoints of Scalp-Specific Investigator Global Assessment score of 0/1 and Psoriasis Scalp Severity Index (PSSI) 90 response at week 16; approximately 90% of patients achieved the co-primary endpoints of complete scalp clearance; significant improvements were observed among patients administered Tremfya in PSSI, Scalp Surface Area, and an approximately 90% improvement from baseline.1
Further, there were no new safety signals observed in this patient population, who the researchers said was previously understudied.1
Additionally, 7 out of 10 patients administered Tremfya showed positive improvements by week 16 in the Scalp Itch Numeric Rating Scale. Major improvements were also reported in Psoriasis Symptoms and Signs Diary and Dermatology Life Quality Index compared to placebo across all skin tones.1
Patients treated with Tremfya reported improvements in Skin Discoloration Impact Evaluation Questionnaire scores, indicating a mild effect from skin discoloration in health-related quality of life.
“Scalp psoriasis can be particularly burdensome to patients as it often impacts more visible areas of the body, including the hairline, forehead, neck, and around the ears, triggering feelings of self-consciousness that limit many people’s lifestyle choices," said Jennifer Davidson, DO, VP, medical affairs, immunology, Johnson & Johnson Innovative Medicine, in a company press release. "The VISIBLE study suggests that people of color continue to experience undertreatment, with many participants not receiving a biologic option prior to this trial enrollment. The insights from the study aim to empower diverse patients with moderate to severe plaque and scalp psoriasis to learn more about their treatment options and initiate informed discussions with their providers."
Back in October, Johnson & Johnson presented data from the Phase IIIb GUIDE trial highlighting early intervention of psoriasis with Tremfya at the European Academy of Dermatology and Venereology. According to the company, results indicated that those treated with Tremfya with short disease duration of psoriasis were extended beyond high levels of Psoriasis Area and Severity Index responses. The investigators said the results support possible tailored therapeutic strategies, addressing individual patient needs.2
"The breadth of data we are presenting at EADV underscores our commitment to developing new treatments for people living with moderate to severe plaque psoriasis, a disease that can cause significant physical and emotional burden," said Lloyd Miller, MD, PhD, VP, immunodermatology disease area stronghold leader, Janssen Research & Development, LLC, in a company press release. "Patients are waiting for a new option with the goal of helping manage their plaque psoriasis symptoms, which could potentially transform the treatment paradigm. The data from these presentations add to the comprehensive body of scientific evidence for our investigational and established therapies, potentially offering people living with moderate to severe plaque psoriasis much-needed relief from their symptoms."2
References
1. TREMFYA® (guselkumab) Demonstrates Significant and Rapid Scalp Psoriasis Clearance in People of Color in New Large Phase 3b Study. Johnson & Johnson. January 22, 2024. Accessed January 24, 2024. https://www.janssen.com/tremfya-guselkumab-demonstrates-significant-and-rapid-scalp-psoriasis-clearance-people-color-new
2. Janssen Highlights Latest Research for TREMFYA® (guselkumab) and Investigational Targeted Oral Peptide JNJ-2113 in Moderate to Severe Plaque Psoriasis at the European Academy of Dermatology and Venereology (EADV) Congress. PR Newswire. October 9, 2023. Accessed January 24, 2024. https://www.prnewswire.com/news-releases/janssen-highlights-latest-research-for-tremfya-guselkumab-and-investigational-targeted-oral-peptide-jnj-2113-in-moderate-to-severe-plaque-psoriasis-at-the-european-academy-of-dermatology-and-venereology-eadv-congress-301949936.html
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